BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 6169999 · Received December 13, 2016

    Report

    Report Number
    1820334-2016-01572
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    July 19, 2016
    Report Date
    July 18, 2017
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION - EVALUATION A REVIEW OF DOCUMENTATION, COMPLAINT HISTORY, TRENDS, AND INSTRUCTIONS FOR USE (IFU) WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND CORRECT DEPLOYMENT PROCEDURE. PER THE IFU "UNLESS MEDICALLY INDICATED DO NOT DEPLOY IN A LOCATION THAT WILL OCCLUDE ARTERIES NECESSARY TO SUPPLY BLOOD FLOW TO ORGANS OR EXTREMITIES. DO NOT COVER SIGNIFICANT RENAL OR MESENTERIC ARTERIES(EXCEPTION IS THE INFERIOR MESENTERIC ARTERY) WITH THE ENDOPROSTHESIS. VESSEL OCCLUSION MAY OCCUR. INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ENDOVASCULAR GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. RENAL ARTERY PATENCY MUST BE MAINTAINED TO PREVENT/REDUCE THE RISK OF RENAL FAILURE AND SUBSEQUENT COMPLICATIONS." POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: RENAL COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS( E.G., ARTERY OCCLUSION, CONTRAST TOXICITY, INSUFFICIENCY, FAILURE)" ADDITIONALLY "ANNUAL IMAGING FOLLOW-UP SHOULD INCLUDE ABDOMINAL RADIOGRAPHS AND BOTH CONTRAST AND NON-CONTRAST CT EXAMINATIONS. IF RENAL COMPLICATIONS OR OTHER FACTORS PRECLUDE THE USE OF IMAGE CONTRAST MEDIA, ABDOMINAL RADIOGRAPHS, NON-CONTRAST CT AND DUPLEX ULTRASOUND MAY BE USED. THE COMBINATION OF CONTRAST AND NON-CONTRAST CT IMAGING PROVIDES INFORMATION ON ANEURYSM DIAMETER CHANGE, ENDOLEAK, PATENCY, TORTUOSITY, PROGRESSIVE DISEASE, FIXATION LENGTH AND OTHER MORPHOLOGICAL CHANGES." RENAL OCCLUSION MAY DEVELOP AS A RESULT OF PATIENT COMORBIDITIES SUCH AS RENAL STENOSIS, ETC. THAT ARE OFTEN TIMES ASSOCIATED WITH ANEURYSM AND PROGRESSIVE ARTERIAL DISEASE. ACCIDENTAL COVERAGE (FULL OR PARTIAL) OF THE RENAL ARTERY DURING PLACEMENT OF THE STENT GRAFT MAY CAN ALSO RESULT IN RENAL OCCLUSION. PER THE IFU INCLUDES STATEMENTS IDENTIFYING THAT THE RENAL ARTERIES SHOULD NOT BE INTENTIONALLY COVERED UNLESS MEDICALLY NECESSARY AND THAT MISDEPLOYMENT OR COVERAGE OF THE RENAL ARTERIES CAN LEAD TO RENAL OCCLUSION. BASED ON THE PROVIDED INFORMATION AND RESULTS OF THE INVESTIGATION; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. MONITORING FOR SIMILAR COMPLAINTS WILL CONTINUE.

    Additional Manufacturer Narrative · 1

    THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE JOURNAL ARTICLE, "FOURTEEN-YEAR OUTCOMES OF ABDOMINAL AORTIC ENDOVASCULAR REPAIR WITH THE ZENITH STENT GRAFT." THE OBJECTIVE OF THE STUDY WAS TO INVESTIGATE THE LONG TERM OUTCOMES OF ENDOVASCULAR AAA REPAIR (EVAR) USING THE ZENITH ENDOGRAFT, STILL IN USE WITHOUT MAJOR MODIFICATION, IN A SINGLE CENTER EXPERIENCE. OF THE 610 PATIENTS WHO PARTICIPATED IN THE STUDY, 567 (93%) OF THEM WERE MALE AND THE AVERAGE AGE OF THE PATIENTS WAS 73.7 YEARS. ON PAGE FOUR IN THE RESULTS SECTION, THE ARTICLE STATES THAT ONE OF THE PERIOPERATIVE DEATHS IS ATTRIBUTABLE TO RENAL FAILURE SECONDARY TO OCCLUSION OF THE RENAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821505 UNKNOWN MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death